Monday, September 29, 2008
Marion Munley and Dan Munley - Chicago Tractor-Trailer Seminar


Marion Munley will be speaking in Chicago at a seminar for the Interstate Trucking Litigation Group on October 1-4, 2008. Her topic is "Discovery in Trucking Cases."

Daniel W. Munley will be speaking in Chicago at a seminar for the Interstate Trucking Litigation Group on October 1-4, 2008. His topic is "What to Do After a Truck Collision."
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posted by Munley Attorney @ 12:06 PM

Tuesday, September 16, 2008
Vote and Pay Tribute to the U.S. Constitution


Constitution Day will be celebrated on Sept. 17 during this presidential election year – as the nation’s voters ponder the election of the country’s first black president or its first woman vice president.

Therefore, it is worth looking back on the crucial roles our Constitution and Bill of Rights have played in ensuring electoral fairness and voting rights for all Americans, regardless of race or gender.

Since the Constitution was ratified on Sept. 17, 1789, and the Bill of Rights ratified some two years later, issues related to voting have been the most predominant subject of subsequent amendments, with at least six that directly affect the electoral process. Article I, Sections 4 and 5, and Article II, Section 1, of the Constitution set forth the processes for choosing U.S. representatives, senators and the president and vice president.

But the election of 1796 and the hotly contested election of 1800, which came down to a contest between Thomas Jefferson and Aaron Burr, revealed a weakness in the method of allocating votes between the two highest offices and resulted in the passage of the 12th Amendment. That amendment requires members of the Electoral College to cast two distinct votes – one for president and another for vice president.

Following the Civil War, in 1870, the 15th Amendment was enacted to prohibit voters from being barred on the basis of race or previous servitude (slavery). Fifty years later, in 1920, the 19th Amendment gave women the right to vote. Without these two amendments, the candidacies of Sen. Barack Obama and Gov. Sarah Palin would never have been possible.
Seven years before women’s suffrage, in 1913, the 17th Amendment changed the method of electing U.S. senators to provide for direct election by the people. Senators had previously been elected or appointed by each of the states’ legislatures. It was to be some time, however, before either a woman, Hattie Wyatt Caraway of Arkansas in 1932, or a person of color, Edward Brooke of Massachusetts in 1966, would be elected by popular vote to the U.S. Senate.
During the 1960s, two more amendments were passed regarding voting rights. In 1961, residents of the District of Columbia were given the right to cast ballots for president when the 23rd Amendment became law. Three years later, the 24th Amendment barred the use of poll taxes. Poll taxes had been enacted in 11 Southern states as a way to prevent black people from voting, and had been ruled unconstitutional by the U.S. Supreme Court. In 1971, amid the turbulence of the Vietnam era, the 26th Amendment gave 18-year-olds the right to vote.
Despite the integral role elections play in our democracy, it is interesting to note that the Constitution doesn’t require American citizens to vote, or even register to vote. Instead, our Founding Fathers left the act of voting – one of only three official acts of citizenship, including serving on juries and serving in the military – up to us.

Given the blood and treasure that those who have gone before us have shed to preserve our freedoms, we would do well to honor those sacrifices and the Constitution by making the effort to vote whenever the opportunity arises.

David I. Fallk is a Scranton attorney and president of The Committee for Justice for All, Kingston. More information is available at this Web address: www.constitutionday.cc.
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posted by Munley Attorney @ 4:07 PM

Monday, September 15, 2008
Thymoglobulin Recall


Anti-Rejection Drug May Not Be Stable

As reported at AboutLawsuits.com on September 10th, 2008 the The U.S. Food and Drug Administration (FDA) posted information Tuesday about a Thymoglobulin recall for one lot of the anti-rejection drug due to stability testing which found samples to be out of specification.

The recall of thymoglobulin applies to lot number C7010C01, manufactured by Genzyme Corp, which was found during visual inspections for stability to have an appearance referred to as opalescence. The impacted lot carries an expiration date of April 2010, and consumers have been warned not to use the drug and to return any unused portions of the product to the manufacturer.

Thymoglobulin is used to reduce the risk of organ rejection in patients who have undergone kidney transplants. It functions by suppressing the immune response of the body. Neither the FDA or Genzyme Corp. posted information about specific health risks the recalled thymoglobulin could cause.

In October 2007, the FDA sent a warning letter to Genzyme regarding violations found at its biologics facility in Lyon, France. The FDA discovered a number of potential problems with quality control and with the purified water system at the plant. Although there is no indication that these violations have any connection to the current recall, the FDA did indicate that these problems could lead to impurities in Genzyme’s drugs. At least two other thymoglobulin recalls have been issued by Genzyme Corp this year for similar stability problems. In Feburary 2008 a recall was issued for lot number CG025CAA, with an expiration date of Nov 2009, and in April 2008 a recall was issued for three additional lots (C7014C01 with expiration date May 31, 2010; C7008C01 with expiration date March 31, 2010 and TH175-05 with expiration date October 4, 2009).

All of the Genzyme recalls were initiated after the products failed periodic stability tests based on the appearance of the product. The specifications for the appearance of reconstituted Thymoglobulin solution is a clear, limpid to slightly opalescent liquid. Some of the samples from recalled lots were found to have exceeded the slightly opalescent stability specification based on visual examinations.
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posted by Munley Attorney @ 6:08 PM

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